Act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety
Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to the SRL operating from a SSRM DA-Cluster.
Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product.
Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WMS/PSSR Authors.
Performs ad hoc special scholarly Safety Surveillance and Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.
Identifies opportunities for Consistency and Standards for Safety Surveillance and Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.
Innovates, champions and implements novel approaches to Safety Surveillance and Risk.
Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research and Communications activities, including methodological improvements.
Engages in inspection readiness and support.
Provision of data to project managers for metrics and activity tracking.
Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums.
Contributes SSRM perspective and subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority Queries and other documents as required.
Prepares basic action plans independently to address risk and benefit-risk issues.
Handles more advanced/complex plans with direction/coaching.
Conducts and Represents SSRM on due diligence activities.
Provides guidance and/or oversight to SSRM colleagues on safety issues.
Provides formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics.
Represent WWS on safety and benefit-risk issues to external groups including regulatory authorities and business partners.
Contributes to review and development of intradepartmental policies and procedures as appropriate.
Initiates, conducts and chairs Risk Management Committee, P-BRC (co-chair) and CWGs with minimal oversight.
Prepares and contributes to written safety assessments and benefit-risk evaluations.
Reviews safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues.
Completes all assigned activities with minimal guidance.
Makes decisions based on clinical experience.
Utilizes knowledge of integrated body systems’ pathophysiology to evaluate the impact of product issues.
Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
Ensures products fulfil quality medical care.
Preferred Health professional degree
Familiarity with safety surveillance software
Technical Skills, (plus knowledge, experience and ability in):Safety data review, Safety data assessment, Clinical Safety signal identification, risk
Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance's
Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle
Demonstrated leadership in day-to-day activities and collaborative skills
Demonstrated self-awareness and interpersonal skills